100+ Interview Questions and Answers

Pharmacy is the science and technique of preparing, dispensing, and reviewing drugs and providing additional clinical services.

• Pharmacy involves the preparation and dispensing of drugs

• Pharmaceutical companies use various types of chemicals such as active pharmaceutical ingredients (APIs), excipients, and solvents

• APIs are the main active ingredients in a drug that provide the therapeutic effect

• Excipients are inactive substances that help deliver the drug to the body

• Solvents ar...read more

pH is a measure of acidity or alkalinity. Quality control ensures products meet standards. Quality assurance ensures processes meet standards.

• pH is a measure of the concentration of hydrogen ions in a solution, indicating its acidity or alkalinity

• Quality control involves inspecting and testing products to ensure they meet predetermined standards

• Quality assurance focuses on ensuring that processes and procedures are in place to consistently produce products that meet quality s...read more

Therapeutic effect refers to the positive impact of a medical treatment on a patient's health. GDP stands for Good Distribution Practice.

• Therapeutic effect is the desired outcome of a medical treatment

• It can be measured by improvements in symptoms or overall health

• For example, the therapeutic effect of an antibiotic is the elimination of an infection

• GDP is a set of guidelines for ensuring the quality and safety of pharmaceutical products during distribution

• It includes require...read more

The type of chemical used in standardized test depends on the test being conducted.

• Different tests require different chemicals for accuracy and reliability.

• Chemicals used in standardized tests are often highly purified and standardized themselves.

• Examples of chemicals used in standardized tests include reagents like Benedict's solution and litmus paper.

• Other chemicals used in standardized tests include acids, bases, and indicators.

• The choice of chemical depends on the nature ...read more

Assay is a test to determine the potency or purity of a drug or substance.

• Assay is done to ensure that the drug or substance meets the required standards.

• It helps in determining the concentration of the active ingredient in a drug.

• Assay can also be used to detect impurities or contaminants in a drug.

• It is an important part of quality control in the pharmaceutical industry.

• Examples of assays include HPLC, GC, and spectrophotometry.

Semipermeable membrane is a type of membrane that allows certain molecules to pass through while blocking others.

• It is a thin layer of material that selectively allows certain molecules to pass through

• Examples include cell membranes and dialysis tubing

• The membrane is made up of tiny pores or channels that allow small molecules to pass through

• It is used in various applications such as water filtration and drug delivery systems

Yes

• Yes, I have faced data integrity issues in my previous role as a Senior Executive.

• One example is when we encountered duplicate records in our customer database, which led to inaccurate reporting and analysis.

• To solve this issue, we implemented a data deduplication process that involved identifying and merging duplicate records based on specific criteria such as name, contact information, and purchase history.

• Another data integrity issue we faced was data inconsistency acro...read more

High and low permeability membranes are used in filtration processes to control the flow of substances.

• High permeability membranes allow for a greater flow of substances through the membrane.

• Low permeability membranes restrict the flow of substances through the membrane.

• Permeability is determined by the size of the pores in the membrane.

• Examples of high permeability membranes include ultrafiltration membranes used in water treatment.

• Examples of low permeability membranes incl...read more

Line clearance is taken to ensure safety and prevent cross-contamination in pharmaceutical manufacturing.

• Line clearance is a procedure followed in pharmaceutical manufacturing to ensure that all equipment, materials, and personnel are removed from a production line before starting a new product or batch.

• It is mentioned in various regulatory guidelines such as Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).

• Line clearance helps prevent cross-contami...read more

Tablet is a solid dosage form of medication. There are several types of dosage forms available.

• Tablet is a compressed solid form of medication.

• It is one of the most commonly used dosage forms.

• Other dosage forms include capsules, injections, syrups, etc.

• Tablets can be coated or uncoated, immediate or extended release.

• Examples of tablets include aspirin, paracetamol, and ibuprofen.

We use a variety of sensors including temperature, pressure, humidity, and motion sensors.

• Temperature sensors are used to monitor the temperature of equipment and environments.

• Pressure sensors are used to measure pressure in systems such as pipelines and tanks.

• Humidity sensors are used to measure the amount of moisture in the air.

• Motion sensors are used to detect movement in areas where security is a concern.

• Other sensors we use include light sensors, proximity sensors, and g...read more

Acidic substances have a pH less than 7, while basic substances have a pH greater than 7.

• Acids release hydrogen ions (H+) when dissolved in water.

• Bases release hydroxide ions (OH-) when dissolved in water.

• Examples of acids include vinegar, lemon juice, and battery acid.

• Examples of bases include baking soda, bleach, and ammonia.

I have handled various equipment as a granulation operator and I am familiar with their working principles.

• I have experience operating granulators, mixers, dryers, and sieves.

• Granulators are used to break down larger particles into smaller granules.

• Mixers are used to blend different ingredients together.

• Dryers are used to remove moisture from the granules.

• Sieves are used to separate granules of different sizes.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original,...read more

Osmosis is the movement of solvent molecules from a region of low solute concentration to a region of high solute concentration through a semi-permeable membrane. Osmotic pressure is the pressure required to prevent the movement of solvent molecules through the membrane.

• Osmosis is a type of passive transport.

• It occurs in living cells and is important for maintaining cell shape and function.

• Osmotic pressure is influenced by the concentration of solutes on either side of the me...read more

Physical compatibility refers to the ability of two substances to be mixed or combined without any physical changes. Chemical compatibility refers to the ability of two substances to be mixed or combined without any chemical reactions.

• Physical compatibility is about the physical properties of substances, such as solubility, viscosity, and stability.

• Chemical compatibility is about the chemical properties of substances, such as reactivity, acidity, and compatibility with other ...read more

The color seen in the test solution depends on the type of test being conducted.

• The color change indicates the presence or absence of a particular substance in the solution.

• Different tests use different indicators to produce a color change.

• For example, a pH test may use litmus paper to indicate acidity or alkalinity.

• A glucose test may use a reagent that changes color in the presence of glucose.

• The color seen in the test solution can be compared to a color chart to determine t...read more

Distillation is a process of separating components of a mixture based on their boiling points. Dilution is the process of reducing the concentration of a solution by adding more solvent.

• Distillation involves heating a mixture to vaporize the component with the lowest boiling point, then condensing the vapor to collect the purified component.

• Dilution is commonly used in chemistry to prepare solutions of a desired concentration.

• Distillation and dilution are both important techn...read more

There are numerous compatibilities in pharmaceutical industry depending on the type of drug, dosage form, and excipients used.

• Drug-excipient compatibility

• Drug-dosage form compatibility

• Excipient-excipient compatibility

• Container-drug compatibility

• Drug-stability compatibility

Chemistry is the study of matter and its properties. Organic chemistry deals with carbon-based compounds while inorganic chemistry deals with non-carbon-based compounds.

• Chemistry is a branch of science that deals with the composition, structure, properties, and reactions of matter.

• Organic chemistry is the study of carbon-based compounds, including hydrocarbons, carbohydrates, proteins, and nucleic acids.

• Inorganic chemistry is the study of non-carbon-based compounds, including...read more

To prepare 0.1 N HCl and NaOH, you need to calculate the required amount of the respective chemicals and dilute them in water.

• Calculate the molar mass of HCl and NaOH

• Determine the volume of solution needed

• Use the formula: Normality (N) = (Number of equivalents / Volume of solution in liters)

• For 0.1 N HCl, calculate the number of equivalents of HCl and dilute it to the desired volume

• For NaOH, calculate the number of equivalents of NaOH and dilute it to the desired volume

• Always...read more

The main reasons for less count in bulk packing are human error, machine malfunction, and inaccurate measurements.

• Human error in counting or packaging

• Machine malfunction or error in the production line

• Inaccurate measurements or weighing of the product

• Lack of quality control or inspection

• Environmental factors such as humidity or temperature

• Improper storage or handling of the product

• Inadequate training of personnel

• Inefficient production processes

• Poor communication between depar...read more

Gas chromatography is a separation technique based on the adsorption of gases or vapours of a liquid by an adsorbent.

• Gas chromatography separates and analyzes volatile compounds in a sample mixture.

• It involves a stationary phase (adsorbent) and a mobile phase (carrier gas).

• The sample is injected into the column and the compounds are separated based on their affinity to the stationary phase.

• The separated compounds are detected by a detector and a chromatogram is generated.

• Gas ...read more

Saliva pH range is typically between 6.2 and 7.6, while water pH range is generally between 6.5 and 8.5.

• Saliva pH range: 6.2 - 7.6

• Water pH range: 6.5 - 8.5

PP in pharmacy stands for Pharmaceutical Product.

• PP refers to the final product that is manufactured by a pharmaceutical company.

• It includes all the ingredients and excipients that are necessary for the product to be effective.

• PP is subject to strict quality control measures to ensure its safety and efficacy.

• Examples of PP include tablets, capsules, injections, and creams.

PIOC stands for Process Input Output Control and POC stands for Process Output Control.

• PIOC is a system that monitors and controls the input and output of a manufacturing process.

• POC is a system that monitors and controls the output of a manufacturing process.

• PIOC ensures that the inputs to a process are within acceptable limits.

• POC ensures that the outputs of a process meet the required specifications.

• Both PIOC and POC are important for maintaining quality control in manufac...read more

Computer systems used in the medical field must be compliant with 21 CFR part 11.

• Electronic medical record systems

• Laboratory information management systems

• Pharmacy management systems

• Clinical trial management systems

• Medical device software

• Electronic data capture systems

CPP for HSG, FBP, Compression, Coating, Blending

• HSG - temperature, pressure, flow rate, and time

• FBP - particle size distribution, moisture content, and bulk density

• Compression - force, speed, and dwell time

• Coating - spray rate, inlet temperature, and atomization pressure

• Blending - mixing time, speed, and order of addition

The main reason for improper sealing of a bottle can be due to various factors such as damaged cap, incorrect torque, or contamination.

• Damaged cap

• Incorrect torque

• Contamination

BP stands for blood pressure. Human anatomy is the study of the structure and organization of the human body.

• BP is a measure of the force of blood against the walls of arteries

• Human anatomy includes the study of bones, muscles, organs, and tissues

• An understanding of human anatomy is important for medical professionals

• Examples of human anatomy include the heart, lungs, brain, and digestive system

Both 21 CFR part 11 and EU Annex 11 are equally precise for computer system.

• Both regulations provide specific guidelines for electronic records and signatures.

• 21 CFR part 11 applies to FDA-regulated industries in the US, while EU Annex 11 applies to pharmaceutical companies operating in the EU.

• Both regulations require validation of computer systems and controls to ensure data integrity and security.

• EU Annex 11 places more emphasis on risk management and data privacy.

• Complianc...read more

Leak test is performed to ensure that there are no leaks in a system. It is mandatory in certain industries.

• To ensure safety and prevent accidents

• To maintain product quality and integrity

• To comply with industry regulations and standards

• Examples: automotive industry, medical devices, HVAC systems

• Different methods of leak testing: pressure decay, vacuum decay, bubble testing, tracer gas testing

HPLC is a technique used to separate, identify, and quantify components in a mixture.

• HPLC uses a liquid mobile phase and a stationary phase to separate components based on their chemical properties.

• It is commonly used in pharmaceuticals, food and beverage, environmental analysis, and forensic science.

• HPLC can detect and quantify very small amounts of compounds, making it a highly sensitive analytical technique.

• Different types of HPLC include reverse-phase, normal-phase, ion-e...read more

Pharmaceuticals can be manufactured through chemical synthesis or bioprocessing (fermentation technique).

• Chemical synthesis involves using chemical reactions to create pharmaceuticals.

• Bioprocessing utilizes microorganisms and cells to produce medicinal substances through fermentation.

• Examples of chemical synthesis include aspirin and paracetamol.

• Examples of bioprocessing include insulin and antibiotics.

Overheads allocation differs for service and manufacturing industries.

• For service industry, overheads are allocated based on the time spent on each project or client.

• For manufacturing industry, overheads are allocated based on the number of units produced.

• Service industry overheads include rent, utilities, salaries, etc.

• Manufacturing industry overheads include rent, utilities, salaries, depreciation, etc.

• Activity-based costing is used to allocate overheads accurately.

• Overhead...read more

It is not possible to provide abbreviations for all equipment, data integration, and procedures in a single answer.

• Abbreviations vary by industry and field

• Equipment and data integration abbreviations may include acronyms such as ERP, CRM, and IoT

• Medical field abbreviations may include EKG, MRI, and CT

• Procedures may have abbreviations such as CPR, ACLS, and PALS

I prioritize tasks based on urgency and importance, delegate when necessary, and use time management techniques.

• Prioritize tasks based on urgency and importance

• Delegate tasks when necessary

• Use time management techniques like creating a to-do list and setting deadlines

• Break down complex tasks into smaller manageable steps

• Utilize tools and technology to streamline processes

• Communicate effectively with team members and stakeholders

Group management daily activity involves overseeing team performance, coordinating tasks, and ensuring effective communication.

• Monitoring team progress and performance

• Coordinating tasks and assigning responsibilities

• Facilitating effective communication within the group

• Providing guidance and support to team members

• Identifying and resolving conflicts or issues

• Tracking project timelines and milestones

• Conducting regular team meetings and updates

• Reviewing and evaluating team perfo...read more

Yes, I faced a problem in a 100 kL fermenter.

• Yes, I encountered issues with temperature control in the 100 kL fermenter.

• There were challenges with maintaining pH levels during fermentation.

• I had to troubleshoot mechanical issues with the agitator in the fermenter.

• Ensuring proper aeration and mixing of the fermentation broth was a constant challenge.

There are various types of gas chromatography gas chamber pipes available.

• The types of gas chromatography gas chamber pipes depend on the application and the type of gas being analyzed.

• Some common types include fused silica capillary columns, packed columns, and micropacked columns.

• The choice of column depends on factors such as the sample size, the type of analyte, and the desired separation efficiency.

• The gas chamber pipes may also vary in terms of their dimensions, coating...read more

Vacuum pumps are used to create a vacuum by removing gas molecules from a sealed chamber or container.

• Vacuum pumps are used in various industries such as food packaging, semiconductor manufacturing, and medical research.

• The process involves creating a low-pressure environment by removing air or gas molecules from a sealed container.

• There are different types of vacuum pumps such as rotary vane pumps, diaphragm pumps, and scroll pumps.

• Examples of vacuum pump applications includ...read more

The lab is equipped with various instruments and devices for conducting technical analysis.

• Microscopes for examining samples

• Spectrophotometers for measuring light absorption

• Centrifuges for separating substances

• PCR machines for DNA amplification

• Gas chromatographs for analyzing chemical compounds

• Electrophoresis equipment for separating molecules

• pH meters for measuring acidity or alkalinity

• Incubators for growing cultures

• Autoclaves for sterilizing equipment

• Balances for weighing s...read more

QA executive plays a crucial role in media fill validation, environmental monitoring, change controls, and deviations.

• Media fill validation ensures that the filling process is free from contamination.

• Environmental monitoring helps to identify potential sources of contamination.

• QA change controls ensure that any changes made to the process are properly documented and reviewed.

• QA deviations help to identify and address any issues that arise during the filling process.

• Past job r...read more

Cost sheet format includes direct and indirect costs. Cost audit report has 4 parts: A - General information, B - Cost accounting records, C - Cost statements, D - Reconciliation.

• Cost sheet format includes direct and indirect costs

• Direct costs include raw materials, labor, and other expenses directly related to production

• Indirect costs include rent, utilities, and other expenses not directly related to production

• Cost audit report has 4 parts: A - General information, B - Cost...read more

The instrument used for filter integrity test is called a bubble point tester.

• Bubble point tester is commonly used for filter integrity test.

• It measures the pressure required to force a gas through the pores of a filter membrane.

• The test helps ensure the filter is functioning properly and has no defects.

• Examples of bubble point testers include Palltronic Flowstar IV and Merck Millipore Integritest.

Compaction sampling is used in Quality Assurance to assess the density and uniformity of compacted materials.

• Compaction sampling helps ensure that compacted materials meet specified density requirements.

• It allows for the identification of any variations in density within a compacted material.

• Compaction sampling helps in evaluating the effectiveness of compaction equipment and techniques.

• It aids in identifying potential issues such as inadequate compaction or non-uniform densi...read more

A solution is a homogeneous mixture of two or more substances, where one substance is dissolved in another.

• A solution is made up of a solute (the substance being dissolved) and a solvent (the substance doing the dissolving).

• The solute particles are evenly distributed throughout the solvent, resulting in a homogeneous mixture.

• Examples of solutions include saltwater (salt dissolved in water), sugar water (sugar dissolved in water), and air (oxygen, nitrogen, and other gases dis...read more

I would first check the equipment for any malfunctions, adjust settings if necessary, and calibrate the humidity sensor.

• Check the equipment for any malfunctions or leaks

• Adjust settings on the humidity chamber to reach the desired humidity level

• Calibrate the humidity sensor to ensure accurate readings

• Monitor the humidity levels regularly to maintain the desired range

Sensors are used in vial washing machines and vial depyrogenated tunnels to ensure proper cleaning and sterilization.

• Sensors detect the presence of contaminants or particles in the vials during the washing process.

• Sensors also monitor the temperature and humidity levels in the depyrogenated tunnel to ensure proper sterilization.

• If the sensors detect any issues, the machine will automatically stop and alert the operator.

• Regular calibration and maintenance of the sensors is nec...read more

Process validation guidelines are a set of principles and procedures used to ensure that a manufacturing process consistently produces products of the desired quality.

• Process validation guidelines help establish and maintain a robust manufacturing process.

• They involve documenting and verifying every step of the process to ensure it meets predetermined specifications.

• Guidelines include defining critical process parameters, conducting process capability studies, and establishin...read more

A line clearance procedure is a systematic process of ensuring that a production line is free from any previous product or material before starting a new production run.

• Line clearance involves removing any leftover materials, tools, or equipment from the previous production run.

• It helps prevent contamination, mix-ups, or errors in the new production run.

• Line clearance procedures are crucial in industries like pharmaceuticals, food production, and electronics manufacturing.

• Exa...read more

Organization culture refers to the shared values, beliefs, attitudes, and behaviors that characterize a company.

• Values and beliefs

• Communication style

• Leadership style

• Employee engagement

• Work environment

• Diversity and inclusion

• Rewards and recognition

Root cause was derived through a thorough investigation and impact was assessed using a risk assessment matrix.

• Root cause analysis involved identifying the underlying factors that contributed to the issue.

• Data was collected and analyzed to determine the root cause.

• Impact assessment involved evaluating the severity and likelihood of the issue occurring again.

• A risk assessment matrix was used to determine the level of risk associated with the issue.

• The impact assessment helped ...read more

To excel in handling payroll functions, one must have strong attention to detail, knowledge of payroll laws and regulations, proficiency in payroll software, and excellent communication skills.

• Ensure accuracy in calculating wages, deductions, and taxes

• Stay updated on payroll laws and regulations to ensure compliance

• Utilize payroll software effectively to streamline processes

• Communicate effectively with employees regarding payroll inquiries and issues

Formulation technology involves the development of methods to create and optimize chemical reactions in order to produce desired products.

• Formulation technology is used in various industries such as pharmaceuticals, cosmetics, and food.

• It involves selecting the appropriate ingredients and determining the optimal ratios and processing conditions to achieve the desired product.

• Chemical reactions play a crucial role in formulation technology as they determine the properties and ...read more

Compounds that can be analyzed using HPLC, GC, and MC.

• Polar compounds are suitable for HPLC analysis.

• Non-polar compounds are suitable for GC analysis.

• Compounds that are thermally stable can be analyzed using MC.

• Examples of compounds suitable for all three techniques include caffeine and aspirin.

RTD stands for Resistance Temperature Detector.

• RTD is a type of temperature sensor that measures temperature by detecting changes in electrical resistance.

• It is commonly used in industrial and scientific applications where accuracy and stability are important.

• Platinum is a common material used in RTDs due to its high accuracy and stability.

• RTDs can be found in various forms such as wire-wound, thin-film, and coiled elements.

• They are often used in conjunction with temperature ...read more

Various safety measures were taken during drug manufacturing to ensure the quality and safety of the drugs.

• Strict adherence to Good Manufacturing Practices (GMP)

• Regular cleaning and maintenance of equipment

• Proper handling and storage of raw materials and finished products

• Regular testing and analysis of samples

• Implementation of safety protocols to prevent contamination and cross-contamination

• Training of personnel on safety procedures and protocols

• Use of personal protective equ...read more

The 'c' in cGMP guidelines is always lowercase because it stands for 'current', not a proper noun.

• The 'c' in cGMP stands for 'current', not a proper noun.

• Lowercase 'c' emphasizes that the guidelines are constantly evolving and being updated.

• It distinguishes cGMP guidelines from other specific guidelines or regulations.

• Example: cGMP guidelines are designed to ensure the quality and safety of pharmaceutical products.

Water content KF reagent is a solution used in Karl Fischer titration to determine water content in a sample.

• KF reagent typically consists of iodine, sulfur dioxide, pyridine, and methanol

• The formula for KF reagent is usually kept confidential by manufacturers

• Different types of KF reagents are available for different types of samples

• The water content in a sample is determined by the amount of KF reagent required to react with the water present

Humidity chambers maintain temperature and relative humidity through a combination of heating, cooling, and humidification systems.

• Humidity chambers use a combination of heating and cooling systems to control temperature.

• Humidification systems are used to control the relative humidity inside the chamber.

• Temperature and humidity sensors are used to monitor and adjust the conditions as needed.

• Examples of humidification systems include steam generators, ultrasonic humidifiers, a...read more

Filling machine can be qualified by performing various tests and inspections.

• Performing visual inspection of the machine

• Checking the accuracy of the filling volume

• Testing the machine's speed and efficiency

• Verifying the machine's compatibility with the product being filled

• Ensuring the machine meets regulatory requirements

• Conducting validation tests to ensure consistent performance

Weight variation in capsule filling machine can be solved by calibrating the machine, checking the quality of raw materials, and optimizing the filling process.

• Calibrate the machine regularly to ensure accurate weighing.

• Check the quality of raw materials to ensure consistency in weight.

• Optimize the filling process by adjusting speed, vibration, and compression.

• Implement quality control measures to detect and reject capsules with weight variations.

• Train operators to follow pro...read more

CPV stands for Cost Per View. It is a metric used in advertising to measure the cost of each view or interaction with an ad.

• CPV is commonly used in online video advertising campaigns.

• It is calculated by dividing the total cost of the campaign by the number of views or interactions.

• CPV helps advertisers understand the effectiveness and efficiency of their ad campaigns.

• For example, if a campaign costs $100 and receives 1,000 views, the CPV would be $0.10 per view.

UV detectors and HPLC detectors are used in research to analyze and quantify substances.

• UV detectors are commonly used in UV-visible spectroscopy to measure the absorption of light by a sample at different wavelengths.

• HPLC detectors are used in high-performance liquid chromatography to detect and quantify the components of a mixture.

• Common types of UV detectors include diode array detectors (DAD) and photodiode array detectors (PDA).

• HPLC detectors can include UV-Vis detectors...read more

I will identify the root cause, involve the team, and implement a solution to prevent future occurrences.

• Identify the problem and its root cause

• Involve the team in brainstorming solutions

• Implement a solution and monitor its effectiveness

• Document the problem and solution for future reference

Cleaning validation is the process of ensuring that equipment and facilities used in manufacturing are properly cleaned to prevent contamination.

• Cleaning validation is a critical part of Good Manufacturing Practices (GMP) in industries such as pharmaceuticals, biotechnology, and medical devices.

• It involves testing and verifying that the cleaning process effectively removes any residues or contaminants from the equipment or facility.

• Validation protocols must be developed and e...read more

Air conditioning works by removing heat and moisture from the air, and then circulating cool, dry air back into the room.

• Air is drawn into the unit through a filter

• The air is cooled by passing over evaporator coils filled with refrigerant

• The cooled air is then circulated back into the room through ducts or vents

• Moisture is removed from the air through condensation

• The warm, moist air is then expelled outside through a separate vent or duct

The work role in quality assurance involves ensuring that products or services meet the required standards and specifications.

• Developing and implementing quality control procedures

• Conducting inspections and audits to identify defects or non-conformities

• Analyzing data to identify trends and areas for improvement

• Collaborating with other departments to ensure quality standards are met

• Training employees on quality control procedures

• Documenting and reporting quality issues and res...read more

UV spectrometry is a technique that measures the absorption or transmission of ultraviolet light by a sample.

• UV spectrometry is based on the principle that different molecules absorb UV light at specific wavelengths.

• It is commonly used in analytical chemistry to determine the concentration of a substance in a sample.

• UV spectrometry can be used to analyze the purity of a compound or identify unknown substances.

• The instrument used in UV spectrometry is called a UV spectrophotom...read more

When media fails, I assess the situation, communicate with stakeholders, and take appropriate corrective actions.

• Assess the impact of the media failure on the organization

• Communicate transparently with stakeholders about the situation

• Identify the root cause of the failure and take corrective actions

• Implement measures to prevent similar failures in the future

To prepare mixing of time to time spatch, ensure all ingredients are measured accurately and mixed thoroughly according to specified instructions.

• Measure all ingredients accurately

• Mix ingredients thoroughly according to specified instructions

• Follow the recommended mixing time

• Ensure proper temperature and humidity conditions for mixing

• Use appropriate mixing equipment

• Check for consistency and uniformity of the mixture

Clinical trials have different phases including Phase 1, Phase 2, Phase 3, and Phase 4.

• Phase 1: Involves a small group of healthy volunteers to determine safety and dosage.

• Phase 2: Involves a larger group to study effectiveness and side effects.

• Phase 3: Involves an even larger group to confirm effectiveness, monitor side effects, and compare to existing treatments.

• Phase 4: Post-marketing surveillance to monitor long-term effects and use in the general population.

I would conduct a thorough analysis of the existing practices and identify areas for improvement.

• I would involve all stakeholders in the process of change

• I would prioritize the identified areas for improvement based on their impact on security

• I would develop a detailed plan for implementing the changes

• I would provide training and support to employees to ensure successful adoption of the new practices

• I would regularly evaluate the effectiveness of the new practices and make ad...read more

Filter integrity test is a method used to ensure that filters are functioning properly and not allowing contaminants to pass through.

• Filter integrity test is performed to check for any leaks or defects in the filter.

• Common methods for filter integrity testing include bubble point testing, diffusion testing, and pressure decay testing.

• Filter integrity testing is important in industries such as pharmaceuticals, biotechnology, and food and beverage.

• An example of a filter integri...read more

Negotiate by highlighting benefits, offering exclusivity deals, and leveraging relationships.

• Emphasize the unique benefits of the product

• Offer exclusivity deals to the supplier

• Leverage relationships with the supplier to negotiate favorable terms

• Explore alternative products or suppliers to create competition

• Consider long-term contracts to secure supply

• Be prepared to walk away if terms are not favorable

Challenge tests in packing involve conducting tests to ensure the packaging materials and processes meet the required standards.

• Challenge tests assess the integrity and performance of packaging materials.

• These tests simulate real-life conditions to evaluate the packaging's ability to protect the product.

• Examples of challenge tests include drop tests, vibration tests, and temperature tests.

• The purpose of challenge tests is to identify any weaknesses or potential issues in the ...read more

Two examples of excipients for delayed release are hydroxypropyl methylcellulose and ethyl cellulose.

• Hydroxypropyl methylcellulose is a water-soluble polymer that forms a protective barrier around the active ingredient, delaying its release.

• Ethyl cellulose is a water-insoluble polymer that forms a coating around the active ingredient, which dissolves slowly in the intestinal tract, delaying its release.

Risk during product development can be mitigated by identifying potential risks early, creating contingency plans, involving stakeholders, and conducting thorough testing.

• Identify potential risks early in the development process

• Create contingency plans for identified risks

• Involve stakeholders in decision-making to gain different perspectives

• Conduct thorough testing to identify and address any potential issues

• Regularly review and update risk management strategies throughout th...read more

The 3 types of liabilities are current liabilities, non-current liabilities, and contingent liabilities.

• Current liabilities are obligations due within one year, such as accounts payable and short-term loans.

• Non-current liabilities are obligations due beyond one year, such as long-term loans and bonds payable.

• Contingent liabilities are potential obligations that depend on the outcome of future events, such as lawsuits or warranties.

The golden rules of accounting are basic principles that guide the process of recording financial transactions.

• The golden rules include: Debit the receiver, Credit the giver; Debit what comes in, Credit what goes out; Debit expenses and losses, Credit income and gains.

• These rules help ensure that financial transactions are accurately recorded and classified in the accounting system.

• For example, when a company receives cash from a customer, the cash account is debited (increas...read more

CSV procedure in automation refers to the process of reading or writing data to and from CSV files in automated scripts.

• CSV (Comma Separated Values) files are commonly used to store tabular data in plain text format.

• In automation, CSV procedures involve reading data from CSV files to use in test scripts or writing data to CSV files as output.

• CSV procedures can be used to automate data-driven testing by storing test data in CSV files and reading it during test execution.

API is the active ingredient in a drug, BULK is the raw material used to make the drug, and Formulation is the final product with the API and other ingredients.

• API stands for Active Pharmaceutical Ingredient, it is the main ingredient in a drug responsible for its therapeutic effect (e.g. acetaminophen in Tylenol)

• BULK refers to the raw materials used to manufacture the drug, such as excipients, binders, and fillers

• Formulation is the final product that contains the API along w...read more

The safety head plays a crucial role in ensuring the safety of employees and compliance with safety regulations.

• Developing and implementing safety policies and procedures

• Conducting safety training for employees

• Performing safety audits and inspections

• Investigating accidents and incidents and implementing corrective actions

• Ensuring compliance with safety regulations and standards

• Collaborating with management and employees to promote a culture of safety

Understanding QMS knowledge and workflow for cc deviation in QMS software is essential for managing production processes effectively.

• QMS knowledge involves understanding quality management systems and their implementation in the production process.

• Workflow for cc deviation in QMS software includes identifying and documenting any deviations from the established quality control standards.

• Effective management of cc deviations in QMS software ensures that production processes mee...read more

The Operations Executive is responsible for overseeing the daily operations of a company and ensuring that everything runs smoothly.

• Develop and implement operational policies and procedures

• Manage and supervise staff

• Monitor and analyze operational performance

• Identify and address operational issues and opportunities

• Collaborate with other executives to develop and implement strategic plans

• Ensure compliance with legal and regulatory requirements

• Manage budgets and allocate resourc...read more

Audit trail is a record of all the activities performed on a system or application.

• It helps in tracking changes made to data and who made them.

• It ensures accountability and transparency.

• It is useful in detecting and investigating security breaches.

• Examples include logs of user activity, system events, and database changes.

F0 value is a measure of thermal heat required to kill microorganisms in food.

• F0 value is calculated using the formula F0 = (t-T)/z

• t is the time required to heat the food to a specific temperature

• T is the reference temperature at which the microorganisms are killed

• z is the heat resistance constant of the microorganisms

• F0 value is used to determine the sterilization process for canned foods

LOD is the limit of detection and Kf is the correction factor used to adjust for matrix effects.

• LOD is the lowest concentration of an analyte that can be reliably detected by an analytical method.

• Kf is used to correct for matrix effects, which are interferences caused by the sample matrix.

• LOD is determined by analyzing a series of samples with known concentrations and identifying the lowest concentration that can be reliably detected.

• Kf is determined by analyzing a sample wit...read more

The process of mixing spatches involves several steps to ensure uniform distribution of ingredients.

• The first step is to accurately measure the required amounts of each ingredient.

• Next, the ingredients are mixed together using a suitable mixing equipment such as a blender or mixer.

• The mixture is then homogenized to ensure uniform distribution of the ingredients.

• Finally, the mixed spatches are tested for quality and consistency before being used in production.

• Example: Mixing s...read more

The procedure for new drug approval involves several stages including preclinical testing, clinical trials, FDA review, and post-market surveillance.

• Preclinical testing is done in laboratories and on animals to assess the safety and efficacy of the drug.

• Clinical trials involve testing the drug on human subjects to determine its safety and effectiveness.

• The FDA reviews the data from preclinical and clinical studies to decide whether to approve the drug for market.

• Post-market s...read more

I can handle the situation by remaining calm, assessing the threat, and taking appropriate action.

• Remain calm and composed to avoid escalating the situation

• Assess the threat level and determine the appropriate response

• Communicate effectively with others involved in the situation

• Take necessary action to resolve the situation while prioritizing safety

• Document the incident and report it to the appropriate authorities

During an audit, it is important to be cooperative, transparent, and prepared.

• Be respectful and courteous to the auditor

• Provide all necessary documentation and information

• Answer questions truthfully and to the best of your knowledge

• Do not argue or become defensive

• Take notes and ask for clarification if needed